FibbroScan and biopsy: In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.
Study summary
The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.
The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients aged 18 years or older who provided written informed consent
2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
3. Patients who schedule to undergo FibroScan examination
Exclusion Criteria:
1. Patients with ascites or pregnant women
2. Patients with any active implantable medical device (such as a pacemaker or defibrillator)
3. Patients who have undergone liver transplantation
4. Patients with cardiac failure and/or significant valvular disease
5. Patients with haemochromatosis
6. Patients who have refused to undergo LB or blood tests
7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease
8. Patients participating in another clinical trial within the preceding 30 days
Primary outcome measure(s)
Diagnostic accuracy — Through study completion, an average of 1 year Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis
Cut-off values — Through study completion, an average of 1 year Optimal thresholds for application on people with obesity
Trial sites (1)
Facility
City
Region
Status
The Third People's Hospital of Chengdu
Chengdu
Sichuan
Recruiting
More The Third People's Hospital of Chengdu trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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